Otolaryngology Coding Alert

Answer: Yes. In a final rule, the U.S. Food and Drug Administration (FDA) establishes a new category of over-the-counter (OTC) hearing aids, enabling patients with mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist. This action — effective Oct. 17, 2022 — aims to stimulate competition to improve access, which may, in turn, lower costs for millions of Americans.

“In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health,” explains the FDA in the rule summary.

Impact: This added competition will mean that otolaryngology practices will have to step up their hearing services game and demonstrate the difference between the OTC hearing devices and true hearing aids fitted by a qualified audiologist.